Pharmacy Law and Ethics (FDA)

Center for Drug Evaluation and Research

Where manufacturers, preparers, and compounders register

Registration

Within 5 days, then annually (30 days after form is received) Hospitals and community pharmacies are exempt, unless they repackage and sell to other retail outlets Subject to biennial inspections (every two years)

1890

Federal law that promoted health

Federal Alcohol Regulations

Bureau of Alcohol, Tobacco, and Firearms Form (FDA ATF-11)- to sell or use Tax free alcohol (ATF-1447) must be for research

Use of Unapproved Medical Devices

Physician may use if not approved or IDE (investigational device exemption) is not approved Life threatening, no alternative, insufficient time Must later substantiate use

Regulations issued by the FDA

Title 21 of the Code of Federal Regulations [21CFR]

Institutional Review Board

All clinical research subject to review

Drug Listing

All marketers required to provide FDA list of drugs introduced to commercial distribution NDC (National Code Directory)

1938-1962

All the drugs on the market were taken off and further tested with the new safety requirements Only about 12% of the drugs were said to have worked effectively for what they labeled to fix

Tamper Resistant Packaging

Alteration to make objectionable, or unauthorized changes Indicator or barrier to entry, to provide visible evidence Five sections to the Act Required on certain OTC products

Good Laboratory Practice (GLP)

Applies to analytical support in safety testing of drug

Guidelines and "Points to Consider"

Assist with compliance, Not regs or laws Pertain mainly to biotech products- "On the Web"

Prescription Drug Marketing Act (PDMA)

Bans sale of drug samples (couldn't track or trace) Reduces health risk from diversion of Rx drugs States license wholesale distribution

Generics

Bioequivalent to pioneer drug, < +/- 20% variance Orange Book: Approved drug products with therapeutic equivalence evaluations

Use of Approved Drugs for Unlabeled Indications

Can be done

Manufacturing

Compliance with CGMP Inspected every 2 years Violations: drugs deemed adultered Quality Assurance: hiring the right people Quality Control

Repackaging

Comply with CGMP

Kefauver-Harris Amendment (1962)

Comply with CGMP (yearly registration) Evidence of Effectiveness (before marketing) Additional labeling requirements Informed Consent Human testing became important: Prisoners were forced to be test dumbies

Cosmetic

Considered adultered if contains poison, unapproved color, filthy, putrid, decomposed or is stored under unsanitary conditions Misbranded!

Product Recal

Defective Drugs Voluntary Recalls (3 classes) (1) strong likelihood of health hazard (2) temporary or reversible health consequence (3) not likely to cause adverse effect

OTC drug

Defined as safe and effective for general public Has 7 point label requirements Misbranded: labeling is false or misleading

Medical Device Amendment

Device defined as an instrument, apparatus, implant, etc. (no chemical action) 3 Classes: (1) pretty safe (2) must be approved before being put on the market (3) very risky EX: heart valves, pace-makers, invetro, etc.

Interim Rule for Expedited Development and Approval of New Drugs

Early consultation with FDA Early agreement on design of phase (2) controlled clinical trails

Drug Efficacy Study Implementation Program [DESI]

Effectiveness of Drugs approved from 1938-1962

Orphan Drug Act

Encourages development of products for rare diseases or conditions < 200,000 people Tax credits and 7 year exclusivity

Patient Information

FDA active role in promoting National Council on Patient Information and Education PPI's: Isoproterenol, Estrogen products, oral contraceptives

Adverse Reaction Reporting (ADR)

Form (FDA 1639) Published in FDA Drug Bulletin

Drug Application and Approval

IND (Initial New Drug) submitted by sponsor: Pcol, tox in animals, human experience. Includes 3 phases of human investigation: (1) normal health volunteers (2) Small study (50-300) patients, treatment vs. control groups (3) large study up to several thousand patients

Fair Packaging and Labeling Act (FPLA)

Identity, net quantity, and names/address on label

Drug Price Competition and Patent Term Restoration Act

Inclueded 2 different Titles (1) abbreviated NDA for generics and their bioequivalency must be shown (2) extension of patent life, not to exceed 14 years from the date of approval

Veterinary Products

NADA: New Animal Drug Application If used in food producing animal- edible products must be free of unsafe residues Flea control product- Topical: EPA regulation, orally Adm: FDA

Drug Master File

Not substitute for IND, NDA, FPLA, ANDA Not required

Ipecac syrup

OTC, 1 ounce Labeling: "Emergency Use" and when not to use Dose: one tablespoonful over 1 year of age Used to make kids throw up

Foreign Prescriptions

Original container and copy of prescription "Exporting Medicine" labeling Must be directly mailed to the patient the prescription is for

Child Resistant Packaging

Poison Prevention Packaging Act of 1970 (PPPA) Consumer Product Safety Commission (CPSC) responsible for administering and enforcing requirements Enforced under both Federal Hazardous Substances Act or FDCA Exemption at request of physician or patient (ex: easy open)

Treatment IND

Possible to use experimental drugs Life threatening or serious disease or no alternative

Drug Export Amendment Act

Public awareness of other countries and the devastating illnesses they are facing Three tracks for FDA approval of exported drugs: (1) If the country approves of the drug (2) (3) vaccines

1906

Pure Food and Drug Act: prohibited misbranding (false-labeling) and adulteration

Medical Advertising

Regulated by FDA, FTC, U.S. Postal Service

Federal Food, Drug, and Cosmetic Act (1938) [FDCA]

Required the new drug to be determined safe Required directions for use Required adequate warnings "prescribed" drugs were exempt (doctors wrote the directions)

New Drug Application (NDA)

Sponsor has enough evidence of safety and effectiveness NDA is submitted to FDA Evaluation and approval

1848

The first law protecting people from harmful imported drugs

Methadone

Treatment program approved by State authority FDA and DEA grants approval Apply to Div. of Scientific Investigations HFD-340

Biological Product

Vaccines, various toxoids, skin test substances, blood and blood products for transfusion Manufacturer license issued by CBER (Center for Biologics Evaluation and Research)

Drug Quality Reporting System (DQRS)

Voluntary Labeling defective, performance failure, packaging poor

Durham-Humphrey Amendment

defined Rx drugs "legend drugs" to distinguish between OTC drugs Rx drugs had to be called into the pharmacy Doctors could buy the prescription drugs and sell them themselves

Sulfanilamide Disaster

diethylene glycol was used as a vehicle to make a tablet into a liquid dosage form and it killed many people which led to the Federal Food, Drug, and Cosmetic Act of 1938